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Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel

NCT00749710 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-09-09

No results posted yet for this study

Summary

Patients suffering from femoral neck or pertrochanteric fractures have a high rate of mortality and morbidity associated mainly with deconditioning and immobilization. Surgical management including open reduction and internaql fixation has been shown to reduce complication and improve outcome in such patients. Delay of surgery produces less optimal results and is associated with higher morbidity even after 24-48 hours of fracture event.

Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery and related complications, as demonstrated in patients treated with Aspirin. However, cessation of antiaggregant therapy before surgery may be associated with complications of a hypercoagulable state and surgery delay.

Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin treatment in ischemic heart disease and cerebrovascular disease patients as well as in primary prevention of stent restenosis.

No data regarding complications of hip surgery in patients treated with Clpopidogrel is available.

Study hypothesis:

Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction and internal fixation of pertrochnteric and femoral neck fractures is safe although associated with more extensive blood loss during surgery and postoperative wound complications.

Conditions

  • Femoral Neck Fractures
  • Pertrochanteric Fractures
  • Antiaggregant Therapy

Interventions

PROCEDURE

clopidogrel

ORIF - surgical treatment

PROCEDURE

no antiaggregant therapy

ORIF - surgical treatment

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ely Steinberg, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749710 on ClinicalTrials.gov